FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHOCK-PATCH ADULT DEFIBRILLATION PADS
K Number: K920086
·
Decision Feb 3, 1992
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
27
Review Days
26
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Basic Information
- Device Name
- SHOCK-PATCH ADULT DEFIBRILLATION PADS
- K Number
- K920086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardiotronics, Inc.
- Date Received
- January 8, 1992
- Decision Date
- February 3, 1992
- Product Code
- LDD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | FDA class 2 | Cardiovascular |
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Other Clearances by Cardiotronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932903 | EKG VEST | Feb 24, 1995 | Substantially Equivalent |
| K922064 | MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE | Dec 1, 1992 | Substantially Equivalent |
| K923297 | MODEL #340 STEALTH-TRODE+LS | Sep 18, 1992 | Substantially Equivalent |
| K922173 | MODEL # 830 ST ADULT STIMULATION PADS (STERILE) | Jun 11, 1992 | Substantially Equivalent |
| K922227 | MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE | Jun 11, 1992 | Substantially Equivalent |
| K922172 | MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) | Jun 11, 1992 | Substantially Equivalent |
| K921606 | MODEL #125 CHILD STIMULATION PADS | May 26, 1992 | Substantially Equivalent |
| K914725 | COORDINATOR, CABLE INPUT | Nov 5, 1991 | Substantially Equivalent |
| K911456 | MODEL #110 STEALTH-TRODE CHILD DEFIB PADS | Oct 16, 1991 | Substantially Equivalent |
| K912621 | MODEL #911 STEALTH MULTI PADS | Oct 16, 1991 | Substantially Equivalent |